POS0359 SEX-RELATED INEQUITY IN RANDOMIZED CONTROLLED TRIALS IN PSORIATIC ARTHRITIS: A SYSTEMATIC LITERATURE REVIEW AND META-ANALYSIS
Authors: L. Eder, S. Mylvaganam, J. Pardo Pardo, J. Petkovic, V. Strand, P. J. Mease, K. Colaco
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Sex is an important determinant of health including response to therapy. Limited information exists on representation and reporting of results by sex in randomized controlled trials (RCTs) in patients with psoriatic arthritis (PsA). <h3>Objectives</h3> Through a systematic literature review and meta-analysis of RCTs in PsA, we aimed to assess potential health inequities in sex-related dimensions by describing the proportion of trials reporting sex-disaggregated data and by comparing the efficacy of advanced therapies between male and female participants. <h3>Methods</h3> We performed a systematic literature search of Medline, Embase and Central databases, and conference abstract archives from January 1, 2000 to June 30, 2022. We included RCTs that reported sex-disaggregated results and assessed the efficacy of an advanced therapy (biologic or targeted synthetic) in adult participants with PsA. Efficacy end points included the proportion of participants achieving minimal disease activity (MDA) or meeting the American College of Rheumatology 20 (ACR20) and ACR50 response criteria at the primary endpoint of the trial. We used random-effect models to calculate pooled effects for responses in males vs. females for the different classes of advanced therapies (Odds Ratio (OR) and 95% Confidence interval (CI)). <h3>Results</h3> We included a total of 52 RCTs, accounting for 21,769 participants, in the review. An equal participation of male and female patients was found (50.1% male participants). Only 9 trials (17.3%, 5,604 participants) reported sex-disaggregated baseline characteristics, 16 trials (30.7%, 9,028 participants) reported sex-disaggregated efficacy endpoints and 2 trials (3.8%, 1,005 participants) reported sex-disaggregated safety endpoints. Female patients had significantly higher baseline tender joint count, Health Assessment Questionnaire Disability Index, physician and patient global assessment of disease activity and pain scores. Male patients had significantly higher baseline psoriasis area and severity index (PASI) and CRP. Differences in pooled estimates of efficacy endpoints were evident for male and female patients across the different classes of advanced therapies. The probability of achieving ACR20 responses was significantly higher in male vs. female patients for IL-17 inhibitors (i) (OR 1.76, 95% CI 1.33, 2.34), IL-23i (OR 1.46, 95% CI 1.20, 1.78), IL-12/23i (OR 2.66, 95% CI 1.39, 5.09) and TNFi (OR 1.67, 95% CI 1.20, 2.34), but not for JAKi (OR 1.10, 95% CI 0.87, 1.38). [<b>Figure 1A</b>] Similarly, the probability of achieving ACR50 responses was significantly higher in males vs. females with all advanced therapies, except JAKi (OR 1.09, 95% CI 0.73, 1.62) <b>[Figure 1B]</b>. The probability of achieving MDA was higher in males across all classes of advanced therapies, including IL-17i (OR 1.99, 95% CI 1.50, 2.63), IL-23i (OR 1.79, 95% CI 1.29, 2.50), TNFi (OR 2.62, 95% CI 1.54, 4.44) and JAKi (OR 1.77, 95% CI 1.15, 2.73) and IL-12/23i (OR 1.82, 95% CI 0.97, 3.40). Male and female patients had similar probabilities for achieving ACR20 responses when using placebo (OR 1.04, 95% CI 0.86, 1.27). <h3>Conclusion</h3> Based on the reported results, female patients participating in RCTs are less likely to achieve efficacy end points for most classes of advanced therapies. Some differences in responses were found across classes of advanced therapies. RCTs should report sex-disaggregated results to identify sex-related differences in efficacy and safety outcomes which will inform patient-centered therapeutic strategies. <h3>REFERENCES:</h3> NIL. <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> Lihi Eder Grant/research support from: Received educational and research grants from Abbvie, UCB, Pfizer, Janssen, Novartis, Eli Lilly, Sandoz, Fresenius Kabi, Sivakami Mylvaganam: None declared, Jordi Pardo Pardo: None declared, Jennifer Petkovic: None declared, Vibeke Strand: None declared, Philip J Mease Speakers bureau: Abbvie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Consultant of: Abbvie, Acelyrin, Aclaris, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Immagene, Janssen, Moonlake, Novartis, Pfizer, Sun Pharma, UCB, Grant/research support from: Abbvie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sun Pharma, UCB, Keith Colaco: None declared.